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Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

MSI S-500L RF Generator

This 510(k) submission (K041980) for the MSI S-500L RF Generator provides limited information regarding specific acceptance criteria and study details. The document focuses on demonstrating substantial equivalence to a predicate device through general performance testing rather than providing detailed quantitative acceptance criteria and a standalone clinical study report.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "Performance testing was done to validate its intended use." However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for the MSI S-500L RF Generator. The evaluation primarily relies on comparison to a predicate device.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/algorithm-based device for which this information would typically be relevant. This is an electrosurgical generator, and "performance testing" usually refers to bench testing, electrical safety, electromagnetic compatibility, and functional verification, not clinical data sets in the AI sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as this is not an AI/algorithm-based device and no clinical "ground truth" establishment by experts is described in the provided text.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for an electrosurgical generator's performance would likely be based on established engineering standards, electrical performance specifications, and safety benchmarks, not clinical ground truth in the context of imaging or diagnostics.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of available information:

• Acceptance Criteria & Performance: Not explicitly detailed in quantitative terms. The submission states that "Performance testing was done to validate its intended use" and that "The comparison and performance testing results in this 510(k) notification shows MSI S-500L RF Generator is substantially equivalent to predicate device and is safe and effective in its intended use." This implies that the device's performance met the general expectations for such a device, in line with its predicate.
• Study Type: No large-scale clinical study with a "test set" in the typical sense of AI/diagnostic device evaluation is described. The focus is on demonstrating substantial equivalence to a predicate device (MSI S-500 RF Generator K033888) through engineering and functional performance testing.
• Device Type: Electrosurgical Generator, not an AI/ML-based device. Therefore, many of the requested criteria (test set, ground truth, experts, MRMC studies, training set) typically apply to AI algorithms or diagnostic devices and are not relevant or addressed in this document.

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Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

MSI S-500 RF Generator

The provided text is related to a 510(k) submission for the "MSI S-500 RF Generator," an electrosurgical device. Based on the content, this submission is for a medical device that performs electrosurgical cutting and coagulation, not an AI/ML-driven device.

Therefore, the document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement typically associated with a study proving an AI/ML device meets acceptance criteria.

The submission focuses on establishing substantial equivalence to a predicate device (Somnus Model 225 Electro Surgical Generator K963772) based on intended use and technological characteristics. It mentions "Performance testing was done to validate its intended use," but provides no details about this testing, its criteria, or results.

Since the device is an electrosurgical generator, the "performance testing" likely refers to electrical and safety standards, functional verification of coagulation, and perhaps some bench testing or animal studies, rather than clinical trials with human readers and ground truth data as one would expect for an AI/ML diagnostic or assistive device.

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Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

The MSI SA series of disposable electrodes are electrosurgical devices used for coagulation of soft tissue. These devices are designed for percutaneous, laparoscopic or intraoperative use. The device consists of a needle electrode and a handle. For temperature measurement model, the needle contains a thermocouple for monitoring tissue temperature. The needle electrode is housed in an insulated cannula. The handle incorporates an electrical connector for interconnecting to an electrosurgical generator.

The provided text is a 510(k) summary for the MSI SA Electrodes, which is an electrosurgical device. This document focuses on demonstrating substantial equivalence to a predicate device based on intended use and technological characteristics, and therefore describes performance testing rather than a study with acceptance criteria in the context of clinical AI/ML device evaluation.

The 510(k) summary explicitly states: "Performance testing was done to validate its intended use. The comparison and performance testing results in this 510(k) notification shows MSI SA Electrode is substantially equivalent to predicate device and is safe and effective in its intended use."

However, it does not provide the specific details required for the requested table and study information, such as:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: Not mentioned, as it primarily refers to performance testing, not a clinical study on a test set.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no clinical ground truth determination described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No indication of an MRMC study. The device is an electrosurgical tool, not an AI/ML diagnostic tool, so such a study would not be relevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable; the "ground truth" would likely be based on engineering specifications and physical performance tests for an electrosurgical electrode (e.g., coagulation efficacy, temperature accuracy, insulation integrity).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document is for a physical electrosurgical device and focuses on demonstrating substantial equivalence through performance testing, which is a different type of validation than the one typically described for AI/ML-based medical devices with specific acceptance criteria, clinical test sets, and expert-established ground truths. Therefore, the requested information elements are largely not present or applicable in this context.

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Indicated for coagulation of soft tissue. These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding "MSI TA Electrodes" for electrosurgical cutting and coagulation. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it include performance metrics, sample sizes, expert qualifications, or details about ground truth establishment.

Therefore, I cannot answer your request based on the provided input. This document is a regulatory approval letter, not a scientific study report.

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